Measuring body clock genes in people with cortisol-related hormone disorders
Tests body clock gene activity in blood cells of adults with cortisol disorders.
Key facts
- Who runs it
- University of Roma La Sapienza
- Where
- Roma, ItalySee the site
- Trial code
- Registry title
- Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
- Status
- Recruiting
- People taking part
- 44 people, planned
- Started
- 4 Jul 2018
- Expected to end
- 1 Dec 2029
- Type of study
- Interventional, 5 groups
- Treatments tested
- circadian gene expression evaluation
- Record updated
- 20 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-term adrenal insufficiency or active Cushing's syndrome. A later amendment also adds adults with obesity, adults starting glucocorticoid therapy, and control participants.
- Age
- 18 to 80 years
- Sex
- Men and women
- Disease stage
- Primary or secondary chronic adrenal insufficiency, newly or previously diagnosed. Cushing's syndrome (ACTH-dependent or ACTH-independent) in its active phase, new or recurring.
- Earlier treatment
- No systemic glucocorticoid other than hydrocortisone or cortisone acetate (except in the exogenous glucocorticoid group). No medication that interferes with cortisol metabolism within 1 month before the study.
Main reasons for not taking part
- Acute adrenal insufficiency
- BMI greater than 40 kg/m²
- Pregnancy
- Night-shift work
- History of neoplasms in the last 5 years (with some exceptions)
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Primary or secondary chronic adrenal insufficiency, previously or newly diagnosed
- ACTH-dependent or ACTH-independent Cushing's Syndrome diagnosis during active disease (new diagnosis or recidivating); Signed informed consent to participate in the study
Who cannot take part
- severe infections, surgery, trauma requiring hospitalization within 3 months before study entry
- any active blood or rheumatic disorders, and active liver disease in the previous 5 years
- use of medication that interferes with cortisol metabolism within 1 month before study entry
- treatment with systemic Glucocorticoid (GC) therapy other than hydrocortisone (HC), or cortisone acetate (CA); (except for the exogenous glucocorticoid cohort)
- alcoholism and/or drug addictions
- acute adrenal insufficiency
- clinically significant chronic kidney disease
- severe psychiatric diseases
- history of neoplasms in the last 5 years (except for adrenal or pituitary adenoma in Cushing Syndrome, pituitary adenoma or related neolpasms in secondary adrenal insufficiency)
- heart disease with a class III or class IV functional capacity
- use of melatonin, antipsychotic medications, estroprogestinic preparations; Additional inclusion criteria introduced by Protocol Amendment Version 2.1 (approved 2026):; Adults with obesity (BMI ≥30 kg/m²), with or without metabolic syndrome. Adults initiating systemic glucocorticoid therapy for non-endocrine conditions, including respiratory or rheumatologic disorders; Additional control participants, including euthyroid individuals with benign nodular thyroid disease, according to the amended protocol
- clinical or laboratory signs of significant respiratory, hepatobiliary, or pancreatic disease
- pregnancy
- BMI greater than 40 kg/m²
- night-shift workers
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in Italy
- Department of Experimental Medicine, "Sapienza" University of RomeRoma, ItalyContact: Andrea M Isidori, MD,PhDTaking people
About the trial
What the trial wants to find out
This is a multicentric, prospective, intervention study on circadian genes expression in peripheral blood mononuclear cells as biomarkers of circadian rhythm derangement in patients affected by alterations of endogenous glucocorticoids secretion (Cushing's Syndrome during active phase, treatment and under remission and newly or on established glucocorticoid replacement therapy adrenal insufficiency)
The 5 groups in the trial
- Patients with Adrenal InsufficiencyTreatment being tested
Patients with Adrenal Insufficiency established or newly diagnosed, under glucocorticoid replacement therapy.
Treatment: circadian gene expression evaluation
- Patients with Cushing's SyndromeTreatment being tested
patients with adrenocorticotropic hormone (ACTH)-dependent or ACTH-independent Cushing's Syndrome diagnosis during active disease (new diagnosis or recidivating) at enrollment.
Treatment: circadian gene expression evaluation
- Healthy ControlsTreatment being tested
Age-, sex- and BMI- matched patients referring to our center for diagnostic procedures not affected by Adrenal Insufficiency or Cushing's Syndrome.
Treatment: circadian gene expression evaluation
- Arm 4 - Participants with ObesityTreatment being tested
Adults with obesity (BMI ≥30 kg/m²), with or without metabolic syndrome, enrolled to investigate circadian, endocrine, immune, and metabolic alterations associated with obesity.
Treatment: circadian gene expression evaluation
- Arm 5 - Patients Receiving Exogenous GlucocorticoidsTreatment being tested
Adults initiating systemic glucocorticoid therapy for non-endocrine conditions, including rheumatologic or respiratory disorders. Participants will undergo baseline assessment before treatment initiation, followed by assessments after 2-3 weeks and 2-3 months, with optional follow-up at 6 and 12 months.
Treatment: circadian gene expression evaluation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
- Plain-language title
- Measuring body clock genes in people with cortisol-related hormone disordersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04374721, who can take part
- Record updated
- 20 October 2026